The United States sent Gilead Sciences' (GILD.O) remdesivir and Mapp Biopharmaceutical Inc's experimental Ebola antibody drug MBP134 to Uganda last week to help safeguard healthcare workers responding to an outbreak that has infected 60 people and killed 44, U.S. government sources told Reuters.
Wednesday, October 19, 2022
FDA authorizes Novavax's COVID vaccine as booster for adults
The U.S. Food and Drug Administration on Wednesday authorized Novavax Inc's COVID-19 vaccine as a booster for adults.
The booster authorization applies to people who are unable to get updated Omicron-tailored boosters, or those who would choose not to receive any other booster dose of a vaccine.
The regulator's decision is in addition to the earlier clearance for the vaccine as a primary two-shot regimen for those 12 years and above.
The company, however, has been struggling with sales of the vaccine and in August had halved its full-year revenue forecast, saying it does not expect further sales of its COVID-19 shot in the United States this year.
https://finance.yahoo.com/news/1-u-fda-authorizes-novavaxs-145750004.html
Abbott's weak medical device sales, China impact drag shares down
Abbott Laboratories on Wednesday reported lower-than-expected growth in international medical device sales, hit by a strong dollar and supply challenges in China, dragging down shares of the company nearly 7%.
The U.S.-based company's weak medical device sales in markets outside its home country offset the initial enthusiasm over its quarterly beat and an upbeat forecast.
Abbott reported $3.62 billion in overall medical device sales, down 0.5% from last year, as the company faced supply challenges due to lockdowns in China.
J.P. Morgan analyst Robbie Marcus says the issues plaguing the medical device segment "could bleed a bit into" the first quarter next year as well.
Multinational companies such as Abbott and Johnson & Johnson have been hit by the dollar's strength against a basket of currencies, including the sterling and the yen, after the U.S. Federal Reserve ramped up interest rates to tame inflation.
Illinois-based Abbott reported third-quarter worldwide sales of $10.4 billion, down 4.7% from a year ago.
Excluding the foreign exchange impact, overall sales were up 1.3%, while the medical device segment saw 6.4% growth.
COVID-19 test kit sales were $1.7 billion, compared to $2.3 billion in the second quarter, as testing declined amid a slower pace of infections.
Abbott said it expects around $7.8 billion in COVID-19 test sales this year, with $500 million in the fourth quarter, compared to the $6.1 billion it had forecast earlier.
Medical device makers such as Abbott have relied on COVID-19 tests to bring in sales during the peak of the pandemic. However, demand has been slowing as more people get vaccinated and overall cases stabilize.
Abbott's stock had declined 25% this year through Tuesday, as the company also struggled with a shutdown of its baby formula facility at Sturgis, Michigan.
https://finance.yahoo.com/news/abbott-raises-2022-profit-forecast-113518698.html
SOBRsafe Distributor Secures Large Industrial Customer
Butterfield Onsite Drug Testing Converting Customers from Legacy Screening to SOBRcheck Technology
SOBR Safe, Inc. (NASDAQ:SOBR) (SOBRsafe™ or the Company), providers of industry-leading alcohol screening solutions, today announced that a prominent west coast commercial construction company is implementing SOBRcheck™ as the new front line alcohol screening solution for its more than 400 employees across multiple locations. The construction company is an established customer of SOBRsafe distributor Butterfield Onsite Drug Testing, and its conversion to SOBRsafe's advanced safety technology validates the Company's sales strategy.
https://finance.yahoo.com/news/sobrsafe-distributor-secures-large-industrial-120000259.html
Tuesday, October 18, 2022
PTC: Enrollment in US part of Phase 2 Huntington's trial paused for more data
PTC Therapeutics, Inc. (NASDAQ: PTCT) confirmed today that enrollment is active and ongoing for its Phase 2 PIVOT-HD trial of PTC518 for the treatment of Huntington's disease at study sites globally. To date, PTC has received approval for conduct of the planned 12-month study in several European countries as well as Australia.
The Phase 2 PIVOT-HD study consists of two parts; an initial 12-week placebo-controlled part focused on PTC518 pharmacology and pharmacodynamic effect, followed by a 9-month placebo-controlled part, during which blood, CSF, and radiographic biomarker data will be collected.
The study will initially include two dose levels, 5 milligrams and 10 milligrams, with the potential to study a third dose leveraging the titratability of the drug. The approvals received to date for the 12-month study include both the 5mg and 10mg dose levels, as well as a potential third dose pending the results of the first two dosing cohorts.
Enrollment in the 12-week portion of the study began first in the United States and continues globally. To date there have been no treatment-related adverse events reported in the US or outside of the US. However, the FDA has requested additional data to allow the study to proceed in the US. Accordingly, enrollment in the US has been paused while discussions with the FDA continue towards resuming US enrollment.
PTC is working towards sharing data from the 12-week portion of PIVOT-HD within the first half of 2023.
https://finance.yahoo.com/news/ptc-provides-ongoing-global-pivot-200100795.html
Florida record levels of deadly flesh-eating bacteria after Hurricane Ian — killing 6 so far
Flesh-eating bacteria are causing record levels of deadly infections in Florida after Hurricane Ian, state health officials have warned.
The storm ripped through the southeast US late last month, causing devastating floods and killing more than 100 people.
Now that the dust has settled, however, there has been a surge in Vibrio vulnificus infections — a type of bacteria found in warm seawater.
It is sometimes known as a flesh-eating bacteria because it can lead to necrotizing fasciitis, when flesh surrounding a wound begins to die and rot.
There have already been nearly as many infections in the past few weeks in Florida as there were for the whole of 2021.
Six people have died in Lee County as a result of wound infections being exposed to Hurricane Ian flood waters that had entered their home, or during post-storm clean-up.
The department of health in Lee County is warning people who have open wounds or cuts to avoid floodwater or seawater.
V. vulnificus is a highly deadly bacterial infection that kills one in five people it infects, usually by entering the bloodstream and causing sepsis.
Other symptoms include fever, chills, skin lesions, and a deadly drop in blood pressure.
Case numbers for the deadly infection have shot up in Florida this year, though deaths have so far remained steady. The spike is due to flooding from Hurricane Ian, Florida's health department has warned
The infection can occur after eating raw or undercooked seafood, or coming into contact with its juices. People with weakened immune systems — particularly those with chronic liver disease or who take medicine that reduces the body’s ability to fight off germs — are most at risk
Hurricane Ian makes landfall sparking flooding and damage to homes in Fort Myers, Florida. The rise in cases in due to flooding from the hurricane, the Florida department of health in Lee County said
The deadly infections are caused by the V. vulnificus bacterium, referred to as a flesh-eating bacteria as skin infections can lead to necrotizing fasciitis, where the flesh surrounding a wound dies
A record 65 cases of the V. vulnificus infection have been recorded in Florida this year, more than any other year since data collection began in 2008.
There have been 11 deaths in total.
Lee County, which was hardest hit by Ian, has seen four deaths and 29 cases of the infection this year, official data shows.
But there was an ‘abnormal increase due to the impacts of Hurricane Ian’, officials said.
26 of the cases have occurred since the hurricane started on September 29 2022.
The bacteria can enter the body when open cuts, wounds and scratches are exposed to seawater, causing ‘life-threatening wound infections’, the Centers for Disease Control and Prevention (CDC) says.
An infection can also occur when someone consumes raw or undercooked fished.
Roughly one in five people with the infection die, sometimes within a day or two of becoming ill. Others may require intensive care or limb amputations.
Anyone can get the infection, but it can be worse for people with weakened immune systems — particularly those with chronic liver disease or who take medicine that reduces the body’s ability to fight off germs.
The infection is not spread person-to-person.
People with wound infections or who think they may have been exposed to V. vulnificus and are experiencing symptoms should seek medical attention immediately, Florida’s health department advised.
Sewage spills in coastal waters as a result of Hurricane Ian also promote growth of the bacteria, meaning there is an increased risk of infections across the state at the moment.
The health department in County Lee said people should ‘always be aware of the potential risks associated when exposing open wounds, cuts, or scratches on the skin to warm, brackish, or salt water’.
Brackish water is a combination of fresh and salt water, often found where rivers meet the sea.
Officials added: ‘Sewage spills, like those caused from Hurricane Ian, may increase bacteria levels. As the post-storm situation evolves, individuals should take precautions against infection and illness caused by V. vulnificus.’
In 2005, Hurricane Katrina caused 22 cases of V. vulnificus and five deaths.
Wounds at risk of coming into contact with potentially infected water should be covered with a waterproof bandage.
If a wound develops redness, swelling, or oozing, or other signs of infection occur including fever, increasing pain, shortness of breath, fast or high heart rate, or confusion or disorientation, medical care should be sought immediately.
Experts had previously warned of hidden health risks from Hurricane Ian’s storms, including super-asthma.
Intense storms sweep up tons of pollen and other respiratory allergens which can irritate the lungs of asthmatics, intensifying symptoms.
This raises the risk of asthma attacks, with several studies showing they spike during and just after thunderstorms.
This phenomenon is known as thunder asthma or thunder hay fever.
And as flood waters surge into treatment plans they will mix chemicals, human waste and maybe even dead animals with drinking water, making it unsafe to use.
There could also be a wave of mental health issues following the mass destruction.
For some this will lead to behavioral issues as people struggle to cope with loss, including some turning to alcohol and drugs.
BD partners with Biocorp on connected self-injection devices
Medtech giant Beckton Dickinson (BD) has signed a deal with France’s Biocorp to use the latter’s near-field communication (NFC) tags in injectable devices.
The agreement will see Biocorp’s Injay device incorporated in UltraSafePlus prefilled syringes, giving them digital connectivity that can be used to gather information such as injection completed, time and date, type of drug, batch number and expiration date – al coded by the manufacturer when the syringe is assembled.
Injay takes the form of a standard pressure syringe system (PSS) that incorporates an NFC tag on the piston rod that can be used to monitor when the syringe is used, without interfering with the injection process.
The partners intend to use the connected technology on self-administered medicines like biologics, to capture and transmit injection data and monitor patients’ adherence with therapy.
The Injay tag can confirm a complete injection and transfer that information via an NFC reader to a smartphone or tablet for review by a healthcare professional.
“Connected drug delivery devices play an important role in helping biopharmaceutical manufacturers understand and track key trends in patient adherence,” said Matthew Schabacker, general manager of BD’s advanced drug delivery unit.
“Our agreement with Biocorp…further supports BD’s commitment to smart, connected care, enabling care to transition to alternate settings and improving chronic disease outcomes,” he added.
More than five billion prefilled syringes are used each year, and the self-injection market is growing quickly, driven by rising numbers of new large-molecule biologic drugs reaching the market.
Meanwhile there is an ongoing shift in the pharma industry to the use of decentralised clinical trials, where patients are asked to participate remotely, and this has led to greater use of digital, connected technologies to monitor their use of medical interventions.
There has however been relatively little effort to develop connected injectable drug delivery devices, unlike other categories such as inhalers where digital technologies are more widely applied.
The global connected drug delivery market is expected to grow at double digit growth rates over the next decade, according to Biocorp, with the increase fuelled by the transition from acute care settings to home care and greater prevalence of self-administered therapies.
BD is one of the top suppliers of prefilled syringes to the pharma industry, with more than a billion UltraSafePlus devices used in around 40 different products since it was first launched in 2010.
https://pharmaphorum.com/news/bd-partners-with-biocorp-on-connected-self-injection-devices/
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